Flow Health Hub device could be disruptive to medical laboratories, as it will be designed to allow patients to perform their own diagnostic tests to monitor pre-existing conditions
Another biotech company has its eye on medical laboratory testing and wants to bring to market what it describes as a consumer do-it-yourself test device. The company is designing the device to let consumers do fitness monitoring. But it hopes the device will also allow consumers to monitor pre-existing conditions without the need to visit a clinical laboratory.
These are ambitious goals for Cambridge Consultants, a health IT engineering and technology development firm in Massachusetts. The device under development is the Flow Health Hub, which company executives say can bring the power of the clinical laboratory into the home, according to a Cambridge Consultants press release.
Though still in the conceptual phase, the developer suggests that the user-friendly device could negate the need to visit medical laboratories for routine tests. That would save time and money for both patients and their doctors.
How It Works
The Flow Health Hub is a small, disc-shaped, consumer-friendly device that enables health consumers to track their fitness activity and monitor pre-existing conditions without visiting clinical laboratories.
It consists of a reader and a set of color-coded cartridges that collect small samples of bodily specimens. Users select the correct cartridge for the test desired. They then perform a finger stick with the integrated lancet, add a small specimen sample, and insert the cartridge into the reader. The device employs microfluidic technology to perform a range of tests, including lipid, metabolic, renal, and electrolyte panels. It displays the results on a built-in screen in minutes.
It tests small samples of bodily fluids—blood, urine, mucus or saliva—and provides quick results for conditions such as high cholesterol, high blood sugar, or poor renal function. The device’s built-in early warning system would alert users when results fall outside normal ranges. It then provides patients with corrective information. It also functions like a connected bedside terminal, collecting and analyzing health data, and automatically alerting the user’s doctor if medical intervention is advisable.
Diabetics, or patients at risk of heart disease due to high cholesterol, could trend their own health data using historical information about their blood glucose or cholesterol levels stored in the device, the press release points out. Doctors would only be alerted in the event of health problems.
Additionally, the device could track hydration level and other fitness metrics during exercise. It could provide fitness enthusiasts information to maximize their training regime, as well as alert them when to drink more fluids or rest.
Self-diagnostic Devices Empower Fitness-minded People
“Diagnostic technologies have matured, becoming more compact, accessible and affordable,” commented John Pritchard, Ph.D., M.B.A., Commercial Director, Diagnostics and Life Sciences at Cambridge Consultants. He noted that patients and fitness-minded people are increasingly embracing the idea of monitoring their own health.
“The [Flow Health Hub] is a tool to aid preventative care or to help diagnose potentially life-threatening changes in a patient’s health, so that quicker medical intervention or more targeted therapies can be received,” he added.
Though technically still under development, the Flow Health Hub could potentially be very disruptive to clinical laboratories, as payers might very well support the use of devices that save them money. However, as of this writing, no date for delivery of the Flow Health Hub has been announced. Nor have any anticipated dates for ascertaining necessary European government or U.S. Food and Drug Administration (FDA) approvals been given.
When asked for a report on the status of the device, a PR firm representing Cambridge Consultants told Dark Daily, “As of now, the technology is only in concept stage, so we couldn’t accurately forecast when the EU/FDA approvals would occur or when it would be made available to consumers.”
POCT Devices Already Entering Consumer Marketplace
Other consumer laboratory POCT devices are already available in the consumer marketplace, or are expected to come to market soon:
• Cue, developed by Cue, Inc., is a modular, Rubik cube-sized device that uses simple microfluidic laboratory technology to perform five different medical laboratory tests, Dark Daily reported in August, 2014.
• Swiss researchers at École Polytechnique Fédérale de Lausanne (EPFL) [Swiss Federal Institute of Technology] have been developing a smartphone-based coagulation test to help patients on anticoagulation therapy to self-test at home, as Dark Daily reported in June, 2014.
• Ten finalists of the Qualcomm TriCorder XPRIZE are competing to build a portable “Star Trek” tricorder-like device that monitors key bodily metrics and diagnoses at least 15 diseases, as Dark Daily reported in January, 2015.
Clinical Lab Industry Would Benefit from Developing Standards
After 25 years of development on point-of-care testing (POCT) devices for clinical use that employ different cartridges to run in the same device, it’s not surprising that at least one corporation wants to use that diagnostic technology to create a home-use POCT device that can accept different cartridges, thus allowing it to run different tests.
The clinical laboratory industry and the pathology profession would be ahead of the game to develop standards that would enable these home-use POCT devices to feed data into the lab’s information system, thus insuring a complete record of a patient’s cumulative lab test results.
Yes, there are many serious issues about the accuracy of the results produced by these devices, and possible misuse by consumers that would also generate inaccurate test results. But that is true of every new technology and someone, somewhere, is going to be first to solve those challenges.
What will be true is that government health systems and private health insurers will have motives to move testing to the “least-cost” settings, including patient home testing, where they think they can save money.